MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA®; INTRODUCER, CATHETER

Model Number	0052-3025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that patient was presented to physician for cardiogenic shock post open heart surgery.Intra-aortic balloon pump used prior to decision to place introducers/impella pumps.Wired on 150cm 0.035 amplatz wire used for insertion.During access at left femoral guidewire kinked.There was no issue with introducer therefore, decision made to abort use of this access site due to dissection endured relating to previous iabp insertion.During access at right femoral physician forgotten that sheath has twist lock hub, so during procedure once the hub broke, sheath removed and replaced.There was 10 min delay reported and medical intervention is not related to sheath but rather underlying medical condition of patient.Patient did have profound anemia with concern for rp bleed, but it was unconfirmed.Patient died on (b)(6) 2019 because family withdrew care due to futility.No adverse event reported no additional information available.
Additional Manufacturer Narrative
The following sections were updated in follow-up.B4,d10,g4,g7,h2,h3,h6,h10.The device used in treatment.One 14f, 13cm long abiomed introducer sheath was returned from the customer without the dilator.There were no other accessories.One of the orange split caps was detached from the sheath's hub and was not returned for evaluation.The other orange cap was still attached.Visible blood was found on and inside the sheath and sideport tubing.When viewed under a 10x microscope, adhesive was present on both sides of the white hub.The bottom of the orange cap could not be checked for adhesive as it was not returned for evaluation.Adhesive was identified on the hub, but it is difficult to quantify the amount of adhesive.Physician was rocking the dilator back and forth when product issue identified.Based on the available information it appears that the physician did now follow the ifu.No manufacturing defects were found.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections.Per procedure adelante s2s introducer sheath in-process and final inspection: "with naked eye at a distance of 12" to 18", verify the sheath hub and split caps are free of excess silicone oil applied between the seals during assembly.Verify split caps are properly placed and secured onto sheath hub and free of cracks/damages or excessive adhesive." additionally, destructive testing is performed per sampling plan.Inspector is to "insert dilator into sheath, lock dilator hub lock nut.Hold dilator hub with one hand and one of the sheath hub wing with the other hand.Bend the dilator hub to the side until dilator hub lock nut is disconnected from the sheath hub.Split caps should remain in place.There should be no damage and fracture to split cap and tabs." manual break and peel test (sampling plan s4 1.0 reduced) using samples from assembly fit check as described in, manually break the sheath and hub and verify that the seals split easily without extreme elongation.Also verify that the split cap and seals remain secure and do not break free or loosen from the sheath hub.Per ifu : cautions: prior to use, read all package inserts, warnings, precautions, and instructions.Failure to do so may result in severe injury or death.Directions for use: insert vessel dilator into sheath and rotate the dilator cap over valve housing to secure the dilator onto sheath assembly.Thread the dilator/sheath assembly over the guidewire.Advance the dilator and sheath together with a twisting motion over the guidewire and into the vessel.Fluoroscopic observation may be advisable.Attaching a clamp or hemostat to the proximal end of the guidewire will prevent inadvertently advancing the guidewire entire into the patient.Once assembly is fully introduced into the vascular system, separate the dilator cap from the sheath valve housing by rotating the dilator cap off the hub.Corrective action has been completed to address the orange cap detachment issue.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• MDR Report Key: 8692828
• Report Number: 1035166-2019-00050
• Device Sequence Number: 1644016
• Product Code: DYB
• UDI-Device Identifier: 00813502010664
• UDI-Public: 00813502010664
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-16097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR